Frequently Asked Questions
What is a clinical trial?
The US Department of Health and Human Services defines a clinical trial as a research study conducted to evaluate a medical procedure or medical product, such as a drug or device. Not all studies at the University of Arizona involve drugs or interventions; some studies use surveys or evaluate medical records to find new and better ways to help people. Other studies recruit healthy volunteers, or control subjects, to better evaluate and compare their results with those of non-healthy subjects.
The US Food and Drug Administration (FDA) defines a clinical investigation as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the FDAn under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part.
What is a clinical trial Principal Investigator?
A Principal investigator, or PI, is the person responsible for the conduct of the study and the leader of the team investigating the disease or condition. The investigator must be qualified by training and experience to investigate what is being studied. The PI is responsible for ensuring that the study is conducted according to the approved plan and that they will follow the rules necessary to conduct the study.
What happens during a trial?
During a clinical trial, information is gained about a new or existing drug, device, procedure, or practice. This information may include safety, efficacy, and evaluation of the participants’ experience. Participation in a trial is completely voluntary, and participants may withdraw from a trial at any time. The study coordinator or PI will provide you with complete information about the trial, and you will have the opportunity to ask questions before you decide whether or not to participate.
What does participating in a trial involve?
Participation in a clinical trial can involve surveys, phone calls, visits with a study doctor or nurse, and/or drugs or other types of treatment. Although many clinical trials involve new drugs, current drugs approved by the FDA may also be tested for new indications. The study may also involve blood draws, electrocardiograms (EKGs), or other clinical procedures. A study doctor or coordinator will explain all of the procedures, risks, benefits, and costs, and you will have the opportunity to ask questions prior to deciding whether or not to participate. Study participants can withdraw from a study at any time.
I don't have a disease but want to participate in research. Are there any studies for me? What is a "healthy volunteer?"
A healthy control or healthy volunteer is a study participant who does not suffer from the disease or condition being studied. Studies may use healthy volunteers as control subjects to compare them with patients who have the disease or condition being studied. Some studies may have additional criteria for healthy volunteers. For example, studies may want volunteers who don't take any medications, or a study may be recruiting participants who do take a specific medication (e.g., birth control) but are otherwise healthy.
A list of studies that need healthy volunteers is found in the Healthy Volunteers category. Contact the Study Coordinator for more information.
Will I be paid for participating in a trial?
Participants in clinical trials may or may not be compensated. Contact the Study Coordinator for the specific trial in which you are interested for information about compensation as well as potential costs, risks, and benefits.
Who oversees a clinical trial?
An Institutional Review Board (IRB) is a group of people that reviews and monitors research involving human participants. In accordance with federal regulations, an IRB has the authority to approve, require modifications in, or disapprove research. The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research, that the PI is qualified to conduct the study, and that risks are minimized and they are reasonable in relation to anticipated benefits. IRBs review research protocols and related materials (e.g., informed consent documents). IRBs are composed of physicians, scientists, and non-scientists from a wide range of fields and specialties. Many of the studies on this website are overseen by the University of Arizona IRB, known as the Human Subjects Protection Program, while others are overseen by IRBs at other universities, medical centers, federal departments (such as the Veterans Administration Central IRB), or commercial IRBs. IRB members who are involved or have a conflicting interest in the research that is being reviewed are prohibited from participating in IRB review of their study. The Human Subjects Protection Program has additional information available for research participants, which can be found here.